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# Proposed Rule on De Novo Classification Process
- URL: https://www.fdaweb.com/proposed-rule-on-de-novo-classification-process/
- Published: 2018-12-07T12:00:00.000Z
- Updated: 2026-09-15T00:49:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142986

*Federal Register* proposed rule: FDA is proposing to establish requirements for its medical device *De Novo* classification process. It also intends to establish procedures and criteria for *de novo* classification requests. The requirements seek to ensure the most appropriate classification of devices consistent with public health protection, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-07/pdf/2018-26378.pdf?ref=fdaweb.com).